CA2117527A1 - Doppler member having inflatable balloon - Google Patents

Doppler member having inflatable balloon

Info

Publication number
CA2117527A1
CA2117527A1 CA002117527A CA2117527A CA2117527A1 CA 2117527 A1 CA2117527 A1 CA 2117527A1 CA 002117527 A CA002117527 A CA 002117527A CA 2117527 A CA2117527 A CA 2117527A CA 2117527 A1 CA2117527 A1 CA 2117527A1
Authority
CA
Canada
Prior art keywords
balloon
elongate flexible
guide wire
flexible member
ultrasonic transducer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002117527A
Other languages
French (fr)
Inventor
Jeffrey Frisbie
Menahem F. Nassi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardiometrics Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2117527A1 publication Critical patent/CA2117527A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06Measuring blood flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445Details of catheter construction

Abstract

A Doppler guide wire having an inflatable balloon (31) which is inflatable with a balloon inflation medium. An elongate flexible member having proximal and distal extremities. An ultrasonic transducer (16) is secured to the distal extremity of the elongate flexible member. The inflatable balloon (31) is mounted on the distal extremity of the elongate flexible member proximal of the ultrasonic transducer (16). Conductors (22 and 23) are connected to the ultrasonic transducer (16) and extend along the length of the elongate flexible member.

Description

CA2i 1 7527 W O 93/17623 PC~r/US93/01868 _ 1 _ DOPPLER MEMBER HAVING INFLATABLE BALLOON

This invention relates to a doppler guide wire having an inflatable balloon mounted thereon. Dilatation catheters have heretofore been provided as, for example, in U.5. Patent No. 4,582,181. Doppler guide wires have been provided as, for example, in U.S.
Patent No. 5,059,851. However, a need has arisen for balloon dilatation catheters which have ultrasonic c~p~hilities which requirements are not met by the devices di CCl05~M in either of the cited patents.
There is, therefore, a need for a doppler guide wire which has an inflatable balloon mounted thereon which meets these requirements.

In general, it is an object of the present invention to provide a doppler guide wire having an inflatable balloon mounted thereon.

Another object of the invention is to provide a guide wire of the above characters which has a small diameter so that it can be inserted into small and tortuous ves6el6.

W O 93/17623 C A 2 i i 7 5 2 I P~r/US93/01868 Another object of the invention is to provide a guide wire of the above character which is very flexible.

Another object of the invention is to provide a guide wire of the above character in which the balloon can be readily inflated and deflated.

Another object of the invention is to provide a guide wire of the above character which facilitates the making of ultrasonic mea~uL~ ~s to ascertain blood flow velocity.

Additional objects and features of the invention will appear from the following description in which the preferred ~ s are set forth in detail in conjunction with the a: , nying drawings.

FIGURE 1 is a side elevational view partially in cross-section of a doppler guide wire having an inflatableballoon mounted thereon and in~L~L~ting the present invention.

FIGURE 2 is an enlarged detail view of the distal extremity of the guide wire shown in Figure 1.

FIGURE 3 is a cross sectional view taken along the line 3-3 of Figure 2.

Detailed DescriDtion of the Invention In general, the doppler guide wire having an inflatable balloon mounted thereon is comprised of an elongate flexible guide wire having proximal and distal extremities. An ultrasonic trAn~n~r is provided.
~eans is provided for securing the ultrasonic W O 93/17623 C A 2 ~ i 7 5 2 7 P~r/US93/01868 trAnCAnc~r to the distal extremity of the guide wire.
An inflatable balloon is mounted on the distal extremity of the guide wire proximal of the ultrasonic trAnC~ r. A lumen opening into the interior of the balloon extends along the length of the guide wire.
Conductive means is connected to the ultrasonic trAnC~ or and extends along the length of the guide wire.

More specifically, as shown in FIGS. 1 and 2 of the drawings, the doppler guide wire 11 having an inflatable balloon mounted thereon consists of a elongate flexible member 12 serving as a guide wire having proximal and distal extremities 13 and 14. It can have a suitable length as, for example, 150 centimeters and a suitable diameter ranging from 0.025"
to 0.010". The elongate flexible member 12 can be formed of a suitable material such as solid stainless steel or, alternatively, as hereinafter described can be formed of a hollow st~;nleqs steel hypo-tube ranging in diameter from 0.025" to 0.010" with a wall th;~n~ss ranging from .OOln to .003".

An ultrasonic L ~n~ 16 of a suitable type such as d;cclo~cd in U.S. Patent No. 5,059,851 is provided.
Tip means 17 is provided for flexibly securing the ultrasonic L.~~ 16 to the distal extremity 14 of the elongate flexible member 12. In order to impart additional fl~y;h;lity to the tip means 17, the distal extremity 14 of the elongate flexible member 12 is provided with a tapered portion 12a as, for example, of a length 2 to 10 centimeters in which the diameter is tapered down from the original diameter of the elongate flexible member 12 to a diameter of 0.002" to 0.008"
which leads into a flattened portion 12b having a ~A 2 i 1 7~27 W O 93/17623 PC~r/~lS93/01868 thickness ranging .001" x .004" and having a length of 1 to 4 centimeters. A coil spring 21 is provided having a suitable length as, for example, 2 to 10 centimeters and is formed of a material which is preferably radiopaque such as tungsten, platinum, palladium or alloys thereof. The trAncdl~r~r can have a diameter ranging from 0.030" to 0.010".

First and second c~nA~rtors 22 and 23 forming conA--rt~r means are connected to the front and back sides of the ultrasonic trAncAl~rr~r 16 and extend proximally from the trAn-~nr~r 16 through the coil 21. The trAnCA~r~r 16 is secured to the distal extremity of the coil 21 by suitable means such as an adhesive 24 through which the conductors 22 and 23 extend as shown in Figure 2. A
h~icph~rical lens 26 is provided on the front surface of the ultrasonic trAncAllr~r 16 and is formed of a suitable material such as an epoxy.

The proximal extremity of the coil ~pring 21 is ~ecured to the tapered portion 12a of the distal extremity 14 of the elongate flexible member 12 by suitable means such as an adhesive 27 so that at least a portion of the elongate flexible member 12 is free of adhesive, as shown in Figure 2.

It should be appreciated that the means shown for attArhing the L~ A~.r ~ r 16 to the coil or coil spring 21 is only one of several different types of conaL.~Lions which can be utilized. For example, as Aicclo6ed in U.S. Patent No. 5,059,851, the tr~n~~r~r 16 can be provided in a cylinder (not shown) which is secured to the spring. Alternatively, the tr~ncd~r~r 16 can be ~nrAp~--lAted within the distal extremity of w093/17623 CA21 l7~ PCT/US93/01868 the spring 21 or rnrirslllated so that it is positioned forward or distal of the spring 21.

An inflatable balloon 31 is mounted on the distal extremity 14 of the elongate flexible member 12. The balloon 31 can be fabricated from a suitable material such as a heat shrinkable polyethylene which can have a suitable inflated diameter as, for example, ranging from 3.0 to 1.5 mi 11 i- ~rs. The balloon 31 vhen inflated is generally cylindrical as shown. A balloon inflation lumen 32 is provided which opens into the interior of the balloon 31 and extends along the length of the elongate flexible member 12. As shown in Figure 2, the balloon inflation lumen 32 is provided by a flexible elongate tubular member 33 which extends co-axially of the elongate flexible member 12 so that theannular balloon inflation lumen 32 extends substantially the entire length of the elongate flexible member 12. The balloon 31 can be formed integral with the distal extremity of the tubular member 33. The distal extremity 34 of the tubular member 33 distal of the balloon 31 is of reduced diameter and is secured to the distal extremity 14 of the elongate flexible member 12 by suitable means such as the adhesive 27 immediately proximal of the proximal extremity of the spring 21. The tubular member 33 can have a suitable dii ~ ~r as, for example, 0.020" to 0.040" and, preferably, 0.025" to 0.035" with a wall thir~n~se ~LL~I~y~d from 0.001" to 0.005" to provide a lumen 32 ranging from 0.015" to 0.033~. An annular space within lumen 32 of at least .001 inches should be provided for inflating and deflating the balloon 31 with the inflation medium. Spaced apart bands 37 of a suitable radiopi~le material such as gold can be provided within the interior of the balloon 31 adjacent W O 93/17623 C A 2 i 1 7 5 2 7 P(~r/US93/Ot868 the opposite ends of the same to aid in visualizing the position of the balloon 31 during a medical p~ocedu~

Also, it should be appreciated that the distal portion 14 of the elongate flexible member 12 can be of a greater length so that it extends into the adhesive 24 provided for adhering the ultrasonic ~r._.l... r 16 to the distal extremity of the coil spring 21.

A ~y" adapter 41 is provided at the proximal extremity of the elongate flexible member 12 which has the inflation lumen 32 in . icAtion with a port 42 provided on the adapter 41. A male electrical connector 43 is provided consisting of spaced apart electrical contacts 44 and 46 mounted on a tubular insulating number 47 carried by the proximal extremity of the elongate flexible member 12 and connected to the conductors 22 and 23 so that an electrical connection can be made to the ultrasonic trAne~ r 16 for making ultrasonic meaau,~ L~. The adapter 41 forms a fluid-tight seal with the tubular number 47. The male c~nn~ct~r 43 is adapted to be used with a combination connector and torgue device 51 of the type described in cv,,~ ing application Serial No. 549,227 filed July 6, 1990. The device 51 is connected by a-cable 52 to a connector 53. The connector 53 is adapted to be connected to suitable iraL,- ~ation (not shown).

The c~ndu~ 22 and 23 extend ~I-e~eLh,v~ the inflation lumen 32 and insulated from each other, the inflation medium, and from the elongate flexible member 12. The conductors can be left loose in the annular lumen or, alternatively, they can be affixed at spaced apart points longit~i nA 1ly of the elongate flexible W O 93/17623 C ~ 2 1 1 7 5 2 7 PC~r/US93/01868 _ 7 _ member 12. Also, if desired, the conductors 22 and 23 can be secured to the wall of the tubular member 33.
In order to provide further protection from the inflation medium, the conductors 22 and 23 can be shielded by an additional flexible, tubular sheath 51 formed of a suitable material such as plastic extending the length of the conductors 22 and 23.

Operation and use of the doppler guide wire 11 may now be briefly described as follows. Let it be assumed that it is desired to perform an angioplasty ~ocedu,~.
The guide wire 11 is adva--ced through a guiding catheter with the balloon 31 in a collapsed or deflated position until the balloon traverses across the lesion or stenosis to be dilated. The torgue device 51 can be used to rotate the distal extremity 14 of the elongate flexible member and the ~_nc~ 16 to aid in advancing the guide wire through a tortuous vessel.
The positioning of the balloon 31 can be ascertained by observing the position of the rAAiopaquo coil spring 21 and in addition, or alternatively, by vi~ ing the raAiopA~o bands 37 in the balloon to properly position the balloon with respect to the stenosis. It should be appreciated that blood velocity mea_u~ Ls can be made by use of the trAnCA~-or 16 to indicate blood flow in the vicinity of the stenosis before the balloon 31 crosses the stenosis and after the balloon 31 has crossed the stenosis before inflation of the balloon.
Thereafter, the balloon 31 can be inflated to .~s the atherosclerotic material in an attempt to provide an ir.~,~ased opening in the stenosis. The balloon 31 can then be deflated and another blood flow velocity m~ made to ascertain whether or not ir.~,eased flow has been provided.

W O 93/17623 C A 2 1 1 7 5 2 7 -8- PC~r/US93/01868 If a still further increase in flow is desired in the vessel, the balloon 31 can be reinflated for an appropriate period of time to again _ ass the atherosclerotic material. Another velocity meaDu,~ t can then be made. This ~,v~ du,~ can be continued until the desired flow is ~hta;n~. Alternatively, the deflated balloon can be withdrawn from the region which inflation has oc~u..~d and another velocity meaau..
made to ascertain the change in velocity of blood flow prior to and after the balloon inflations have ocuu,.ad to ascertain the efficacy of the ~.v~edu-~ performed.

After it has been ascertained that the maximum performance has been achieved with the doppler guide wire, the doppler guide wire can be removed in a conventional manner.

During blood flow velocity meaDu.~ ts, it may be desirable to rotate the trAn~ 16 by use of the torgue device 51 to optimize the received signal from the trAn~duc~r 16.

It is apparent from the foregoing that there has been provided a doppler guide wire which can be used for ang;opl~ty which makes it possible to make on-~l.L s~u~
velocity r~ s to ascertain the efficacy of the ~.ocedu a being performed. The guide wires are of small diameter so that very small and tortuous vessels having stenoses therein can be treated. The guide wire has a very flexible tip making it possible to negotiate small and tortuous vessels, in particular, by the flexible coil spring 21 u~ed for mounting the ultrasonic ~_n~ and by the use of the torque device 51.

Claims (6)

WHAT IS CLAIMED IS
1. In a doppler guide wire having an inflatable balloon secured thereon which is inflatable with a balloon inflation medium, an elongate flexible member having proximal and distal extremities, an ultrasonic transducer, means securing the ultrasonic transducer to the distal extremity of the elongate flexible member, said inflatable balloon fixedly mounted on the distal extremity of the elongate flexible member proximal of the ultrasonic transducer, a balloon inflation lumen opening into the interior of the balloon and extending along the length of the elongate flexible member for introducing the balloon inflation medium into the balloon and conductor means connected to the ultrasonic transducer and extending along the length of the elongate flexible member.
2. A guide wire as in Claim 1, wherein said balloon inflation lumen is formed by a tubular member extending coaxially over the elongate flexible element to provide an annular lumen extending into the interior of the balloon.
3. A guide wire as in Claim 2, wherein said tubular member and said balloon are formed integral with each other.
4. A guide wire as in Claim 2, wherein said conductor means extends through the balloon inflation lumen.
5. A guide wire as in Claim 1, wherein said means for securing ultrasonic transducer to the distal extremity of the elongate flexible element includes a coil spring.
6. A guide wire as in Claim 4 together with a protective sheath enclosing the conductor means for protecting the conductor means from the balloon inflation medium.
CA002117527A 1992-03-06 1993-03-03 Doppler member having inflatable balloon Abandoned CA2117527A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/848,428 US5226421A (en) 1992-03-06 1992-03-06 Doppler elongate flexible member having an inflatable balloon mounted thereon
US07/848,428 1992-03-06

Publications (1)

Publication Number Publication Date
CA2117527A1 true CA2117527A1 (en) 1993-09-16

Family

ID=25303241

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002117527A Abandoned CA2117527A1 (en) 1992-03-06 1993-03-03 Doppler member having inflatable balloon

Country Status (5)

Country Link
US (1) US5226421A (en)
EP (1) EP0637936A1 (en)
JP (1) JPH07504345A (en)
CA (1) CA2117527A1 (en)
WO (1) WO1993017623A1 (en)

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JPH07504345A (en) 1995-05-18
EP0637936A1 (en) 1995-02-15
EP0637936A4 (en) 1994-12-28
US5226421A (en) 1993-07-13

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